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      Development and clinical application of a rapid IgM‐IgG combined antibody test for SARS‐CoV‐2 infection diagnosis

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          Abstract

          The outbreak of the novel coronavirus disease (COVID‐19) quickly spread all over China and to more than 20 other countries. Although the virus (severe acute respiratory syndrome coronavirus [SARS‐Cov‐2]) nucleic acid real‐time polymerase chain reaction (PCR) test has become the standard method for diagnosis of SARS‐CoV‐2 infection, these real‐time PCR test kits have many limitations. In addition, high false‐negative rates were reported. There is an urgent need for an accurate and rapid test method to quickly identify a large number of infected patients and asymptomatic carriers to prevent virus transmission and assure timely treatment of patients. We have developed a rapid and simple point‐of‐care lateral flow immunoassay that can detect immunoglobulin M (IgM) and IgG antibodies simultaneously against SARS‐CoV‐2 virus in human blood within 15 minutes which can detect patients at different infection stages. With this test kit, we carried out clinical studies to validate its clinical efficacy uses. The clinical detection sensitivity and specificity of this test were measured using blood samples collected from 397 PCR confirmed COVID‐19 patients and 128 negative patients at eight different clinical sites. The overall testing sensitivity was 88.66% and specificity was 90.63%. In addition, we evaluated clinical diagnosis results obtained from different types of venous and fingerstick blood samples. The results indicated great detection consistency among samples from fingerstick blood, serum and plasma of venous blood. The IgM‐IgG combined assay has better utility and sensitivity compared with a single IgM or IgG test. It can be used for the rapid screening of SARS‐CoV‐2 carriers, symptomatic or asymptomatic, in hospitals, clinics, and test laboratories.

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          Most cited references 5

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          IgM in microbial infections: taken for granted?

          Much has been learned about the structure, function, and production of IgM, since the antibody's initial characterization. It is widely accepted that IgM provides a first line of defense during microbial infections, prior to the generation of adaptive, high-affinity IgG responses that are important for long-lived immunity and immunological memory. Although IgM responses are commonly used as a measure of exposure to infectious diseases, it is perhaps surprising that the role of and requirement for IgM in many microbial infections has not been well explored in vivo. This is in part due to the lack of capabilities, until relatively recently, to evaluate the requirement for IgM in the absence of coincident IgG responses. Such evaluations are now possible, using gene-targeted mouse strains that produce only IgM, or isotype-switched IgG. A number of studies have revealed that IgM, produced either innately, or in response to antigen challenge, plays an important and perhaps under appreciated role in many microbial infections. Moreover, the characterization of the roles of various B cell subsets, in the production of IgM, and in host defense, has revealed important and divergent roles for B-1a and B-1b cells. This review will highlight studies in which IgM, in its own right, has been found to play an important role, not only in early immunity, but also in long-term protection, against a variety of microbial pathogens. Observations that long-lived IgM responses can be generated in vivo suggest that it may be feasible to target IgM production as part of vaccination strategies.
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            Production of specific antibodies against SARS-coronavirus nucleocapsid protein without cross reactivity with human coronaviruses 229E and OC43

            Severe acute respiratory syndrome (SARS) is a life-threatening disease for which accurate diagnosis is essential. Although many tools have been developed for the diagnosis of SARS, false-positive reactions in negative sera may occur because of cross-reactivity with other coronaviruses. We have raised polyclonal and monoclonal antibodies (Abs) using a recombinant form of the SARS virus nucleocapsid protein. Cross-reactivity of these anti-SARS Abs against human coronavirus (HCoV) 229E and HCoV OC43 were determined by Western blotting. The Abs produced reacted with recombinant SARS virus nucleocapsid protein, but not with HCoV 229E or HCoV OC43.
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              Comprehensive bedside point of care testing in critical ED patients: a before and after study

              We determined the effects of comprehensive point-of-care testing (POCT) on process of care in critically ill emergency department (ED) patients. We hypothesized that POCT would shorten ED length of stay (LOS), reduce time to test results, and reduce time to completion of intravenous (IV) contrast computed tomography (CT) imaging compared with central lab testing.
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                Author and article information

                Contributors
                tu276025@gird.cn , yefeng@gird.cn
                Journal
                J Med Virol
                J. Med. Virol
                10.1002/(ISSN)1096-9071
                JMV
                Journal of Medical Virology
                John Wiley and Sons Inc. (Hoboken )
                0146-6615
                1096-9071
                13 April 2020
                Affiliations
                [ 1 ] State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease Guangzhou Institute of Respiratory Health, The First Affiliated Hospital of Guangzhou Medical University Guangzhou China
                [ 2 ] The 2nd Hospital of Nanjing Nanjing University of Chinese Medicine Nanjing China
                [ 3 ] Chongqing Public Health Medical Center Chongqing China
                [ 4 ] Union Hospital, Tongji Medical College Huazhong University of Science and Technology Wuhan China
                [ 5 ] The 1st Affiliated Hospital of Nanchang University Nanchang China
                [ 6 ] Department of Pulmonary and Critical Care Medicine Guangdong Second Provincial General Hospital Guangzhou Guangdong China
                [ 7 ] Wuhan No. 1 Hospital Wuhan China
                [ 8 ] The 1st Affiliated Hospital of Xi'an Jiaotong University Xi'an China
                [ 9 ] Jiangsu Medomics Medical Technology Co., Ltd Nanjing China
                [ 10 ] Hunan Provincial Center for Disease Control and Prevention Changsha China
                Author notes
                [* ] Correspondence Feng Ye, State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, The First Affiliated Hospital of Guangzhou Medical University, 510120 Guangzhou, China.

                Email: tu276025@ 123456gird.cn , yefeng@ 123456gird.cn

                Article
                JMV25727
                10.1002/jmv.25727
                7228300
                32104917
                © 2020 The Authors. Journal of Medical Virology Published by Wiley Periodicals, Inc.

                This is an open access article under the terms of the http://creativecommons.org/licenses/by/4.0/ License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited.

                Page count
                Figures: 2, Tables: 3, Pages: 7, Words: 4575
                Product
                Categories
                Research Article
                Research Articles
                Custom metadata
                2.0
                corrected-proof
                Converter:WILEY_ML3GV2_TO_JATSPMC version:5.8.0 mode:remove_FC converted:15.04.2020

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